Focal Salvage HDR Brachytherapy for the Treatment of Pros... | NCT01583920

Studies
Focal Salvage HDR Brachytherapy for the Treatment of Prostate Cancer

NCT01583920

Sponsor

Sunnybrook Health Sciences Centre

Status

Active, not recruiting

Last Update Posted

Nov 27, 2024Actual

Enrollment

60Actual

Phase

Not Applicable

Conditions

Prostate Cancer

Interventions

focal salvage HDR prostate brachytherapy

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2024

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2012

Primary Completion Date

Jul 2028Estimated

Completion Date

Jul 2028Estimated

First Submitted Date

Apr 20, 2012

First Submission Date that Met QC Criteria

Apr 23, 2012

First Posted Date

Apr 24, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 26, 2024

Last Update Posted Date

Nov 27, 2024Actual

Name	Class
Canadian Association of Radiation Oncology	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Radiation therapy is considered a standard treatment option for the management of localized prostate cancer. Among the 20-30% who recur, a proportion of them will present with an isolated local recurrence, meaning no distant metastases. If left untreated, it may serve as a source for subsequent metastases. Salvage options available for isolated local recurrence include; temporary or permanent implantation of radioactive seeds into the prostate, complete removal of the prostate gland, use of low temperatures to treat the disease, and high frequency ultrasound to treat the disease. There are risks of complications associated with all these treatments, and there is presently no consensus as to which treatment is the best. Therefore, the aim of this pilot study is to look at the feasibility and toxicities of focal treatment of the prostate using temporary implantation of radioactive seeds into the prostate which the investigators hope will be less since the entire prostate is not treated.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Focal salvage HDR prostate brachytherapy	Experimental		Radiation: focal salvage HDR prostate brachytherapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
focal salvage HDR prostate brachytherapy	Radiation	Treatment will be delivered using 192-Ir HDR afterloading. Dose prescription is 2 fractions of 13.5 Gy each, delivered 1 week apart.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of acute urinary and rectal toxicities	Common Terminology Criteria for Adverse Events (CTCAE) v4.0	Acute period (<6 months)

Secondary Outcomes

Measure	Description	Time Frame
Incidence of late urinary and rectal toxicities	Common Terminology Criteria for Adverse Events (CTCAE) v4.0	Late period (>6 months)
Biochemical (ie. prostate specific antigen) disease free survival

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Biopsy-confirmed locally recurrent prostate adenocarcinoma > 30months after the completion of XRT, SBRT, LDR or HDR brachytherapy boost with XRT, or LDR or HDR brachytherapy as monotherapy by a stereotactic transperineal biopsy
Staging T2-weighted, DWI and DCE-MRI that demonstrates solitary recurrence confined to prostate, and correlates with stereotactic transperineal biopsy
Staging CT or MRI (abdomen and pelvis) and bone scan are negative for metastases
American Urological Association Symptom Index Score (ie. IPSS) < 15
Baseline (post-XRT) serum PSA < 10 ng/mL
Prostate volume as measured by transrectal ultrasound (TRUS) < 50cc
ECOG performance status 0-1

Exclusion Criteria:

Any of the following prior therapies: transurethral resection of the prostate (TURP), radionuclide (permanent or temporary implantation) prostate brachytherapy, prostatectomy or prostatic cryosurgery, HIFU (high-intensity focused ultrasound), bilateral orchiectomy, chemotherapy for prostatic carcinoma
Evidence of castrate resistance (defined as PSA > 3 ng/mL while testosterone is < 1.7 nmol/L). Patients could have been on combined androgen blockade with initial radiotherapy but are excluded if this was started due to PSA progression.

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Hans Chung, MD	Sunnybrook Health Sciences Centre, Odette Cancer Centre	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sunnybrook Health Sciences Centre, Odette Cancer Centre		Toronto	Ontario	M4N 3M5	Canada

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
40789422	Derived	Paulin G, Morton G, Loblaw A, Tseng CL, Corkum M, Murgic J, Ravi A, Davidson M, Wronski M, Paudel M, Haider M, Deabreu A, Zhang L, Chung HT. Updated results of MR-assisted focal salvage HDR prostate brachytherapy: a prospective study. Radiother Oncol. 2025 Oct;211:111091. doi: 10.1016/j.radonc.2025.111091. Epub 2025 Aug 9.

ID	Term
D005834	Genital Neoplasms, Male
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms